Name: ISO/TS 24560-1:2022 — Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping
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ISO/TS 24560-1:2022 PDF

Tissue-engineered medical products — MRI evaluation of cartilage — Part 1: Clinical evaluation of regenerative knee articular cartilage using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) and T2 mapping

Название (английский):

ISO/TS 24560-1:2022

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 31
Дата публикации:: 14 июля 2022 г.
Издание:: ISO TS 24560 edition 1 version 1
ICS:: 11.040.40

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Описание (английский):

This document provides a principle to determine the parameter settings and operating methods for the evaluation of the composition and structure of articular cartilage by dGEMRIC and T2-mapping MRI in humans with a typical example of the methods; each are distinct MRI technologies that allow for noninvasive observation of soft tissue characteristics. The methods provided in this document are intended for application in the evaluation of the clinical effects of tissue-engineered cartilage or other cartilage regeneration products used in the knee joint, and are also applicable for the evaluation of regenerative cartilage in other joints, although some modification of parameters is needed. This document describes a longitudinal evaluation of the water content, the glycosaminoglycan (GAG) concentration, and the concentration and orientation of collagen fibres in regenerative cartilage when using dGEMRIC and T2-mapping techniques in 1,5 T or 3,0 T magnetic resonance imaging equipment.

Overview

ISO/TS 24560-1:2022 - "Tissue‑engineered medical products - MRI evaluation of cartilage - Part 1" defines principles and recommended methods for the non‑invasive MRI assessment of regenerative knee articular cartilage using delayed gadolinium‑enhanced MRI of cartilage (dGEMRIC) and T2 mapping. The technical specification covers longitudinal evaluation of water content, glycosaminoglycan (GAG) concentration and collagen concentration/orientation using clinical 1.5 T and 3.0 T MRI systems. The methods are intended primarily for clinical follow‑up of tissue‑engineered cartilage (e.g., MACI/MACT) but are adaptable to other joints with parameter modification.

Key topics and technical requirements

Imaging techniques: dGEMRIC (pre‑ and post‑contrast T1 mapping) and T2 mapping as complementary biochemical MRI biomarkers.
Measured parameters: T2 relaxation time, T1 mapping, R1 (=1/T1), and ΔR1 for estimation of fixed charge density and GAG content; evaluation of collagen content and orientation (including depthwise anisotropy/magic‑angle effects).
Equipment and field strength: Procedures targeted for 1.5 T and 3.0 T MRI scanners; requirements for MR equipment, imaging parameters and longitudinal consistency are specified.
Acquisition & post‑processing: Guidance on pulse sequences, regions of interest (ROIs) for regenerative and control cartilage, number of averages, echo/repetition times, slice thickness, field of view, and post‑processing steps for mapping and quantitative measurement.
Study design: Emphasis on longitudinal evaluation, standardized parameter settings, exclusion criteria, and reporting to enable reproducible clinical assessments.
Supporting material: Annex A provides example measurement results and validation data; Annex B introduces T1ρ imaging as an informative complement.

Practical applications

Noninvasive monitoring of cartilage repair and maturation after tissue‑engineered implants (e.g., MACI/MACT).
Quantitative assessment of GAG content and collagen network organization to inform clinical outcomes, device performance, and comparative studies.
Use in clinical trials, registry follow‑up, radiology practice, and translational research assessing regenerative therapies for knee-and with adaptations-hip, ankle or shoulder cartilage.

Who should use this standard

Radiologists and MRI technologists implementing advanced cartilage imaging protocols.
Orthopaedic surgeons and clinicians monitoring regenerative cartilage treatments.
Medical device and tissue‑engineering developers conducting clinical evaluations or regulatory submissions.
Clinical researchers designing longitudinal studies and multicenter trials of cartilage repair.

Related standards (if applicable)

ISO/TC 150 publications on implants for surgery and tissue‑engineered medical products; consult national bodies or ISO for standards on clinical evaluation and device-specific requirements.

ISO/TS 24560-1:2022 PDF

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Abstract

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

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